Efficacy of Jobelyn™ Consumption on Hemoglobin Levels in a Borderline Anemic Population
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01828060|
Recruitment Status : Completed
First Posted : April 10, 2013
Last Update Posted : September 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Anemia||Dietary Supplement: Jobelyn™ Dietary Supplement: Placebo||Phase 1 Phase 2|
From past history, case studies in Nigeria, as well as testimonials from all over the world, have shown a robust increase in hemoglobin within a few weeks in people with serious cases of anemia present under disease conditions such as sickle cell, Malaria, HIV, or cancer. In parallel, improvements in red blood cell health were also seen in many healthy people with general low blood counts due to undetermined factors.
A clinical study on anemia is currently ongoing in Nigeria. The study population is focused on women and aims at evaluating whether Jobelyn™ consumption can help increase hemoglobin and thus reduce risk factors associated with gynecological surgery in a Nigerian cohort of gynecological patients (ClinicalTrials.gov Identifier: NCT01670955).
As a parallel to the ongoing study in Nigeria, this study protocol will help to systematically examine the effects of Jobelyn™ on anemic conditions in an otherwise healthy North American population, and help document the speed and magnitude of improvements in a population without concomitant infections or sickle cell anemia.
Twenty-four human subjects of both genders will be tested over a period of 8 weeks. Both genders may enroll in the study, but we expect more women to be eligible, due to effects of menses and prolonged consumption of birth control pills. Recruiting of volunteers will happen via NIS Labs. A screening blood draw will be used for CBC/differential and the hemoglobin level help determine eligibility.
Enrolled subjects will randomized to consume placebo or Jobelyn™ for 8 weeks, during which time subjects are monitored at baseline, and after 3 days, 7 days, and 2, 4, and 8 weeks. A fasting blood sample will be taken at each visit, and used for hemoglobin and fasting glucose measurements.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Primary Purpose:||Basic Science|
|Official Title:||Efficacy of Jobelyn™ Consumption on Hemoglobin Levels in a Borderline Anemic Population.|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||August 2013|
Dietary supplement Jobelyn™, 500mg daily for 8 weeks Jobelyn is a sorghum bicolor extract marketed as dietary supplement Other Name: Sorghum bicolor extract
Dietary Supplement: Jobelyn™
Sorghum bicolor leaf sheath extract
Placebo Comparator: Placebo
Dietary Supplement: Placebo
- Hemoglobin [ Time Frame: 8 weeks ]Change in hemoglobin levels
- Fasting blood glucose [ Time Frame: 8 weeks ]Change in fasting glucose levels
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828060
|United States, Oregon|
|Klamath Falls, Oregon, United States, 97601|